510(k) · Cleared
ClearedOmegatrac, Model Z105
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teftec Corp. · ITI Wheelchair, Powered
Cleared on Feb 8, 2002 after a 127-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 8, 2002
- Review
- 127 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
Indications for use for the Model Z105 QmegaTrac® Powered Wheelchair base: QmegaTrac® design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity’s that are not candidates for…
Read the full statement (201 words)
Indications for use for the Model Z105 QmegaTrac® Powered Wheelchair base:
QmegaTrac® design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity’s that are not candidates for other types of mobility without extensive modification may be appropriate for the QmegaTrac® with no modifications.
This usage would be indicated but not limited to the following types of injury’s:
Spinal Cord Injury (SCI) Guillain-Barre Syndrome
Head Injury (CHI) Quadriplegia
Muscular Dystrophy (MD) Paraplegia
Cerebral Palsy (CP) Triplegia
Brown Sequard's Syndrome Hemiplegia
Severe Arthritics (RA) (OA) Tetraplegia
Proximal Extremity Weakness
Multiple Sclerosis
Cerebral Vascular Accident (CVA or Stroke)
Huntington’s Corea
Traumatic Brain Injury (TBI) Quadriparesis
Amyotrophic Lateral Sclerosis (ALS) Obesity
Anoxic Encephalopathy Parkinson’s
Anoxia
This is not meant to be an all-inclusive list, anyone needing power assistance with their mobility may be an appropriate client for an QmegaTrac® powered wheelchair. This would usually be decided by clinical evaluation of the client’s strength, sitting balance, mobility needs, size constraints and driving capability at their local rehab facility.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013307 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013307: Omegatrac, Model Z105.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013307
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026